Kornimate/medical-research-clean huggingface dataset:
effect of polydextrose on fecal bulk and bowel function in mildly constipated subjects

Conditions: Constipation; Gastrointestinal Dysfunction

Summary: polydextrose (pdx) (8-30g/day) has been reported to increase faecal bulk and consistency, leading to easier stool passage in healthy subjects. studies on its effect on defaecation frequency and colonic transit time have provided mixed results. the primary objective was to investigate the effect of pdx consumption by mildly constipated subjects on faecal bulk, measured as total faecal wet weight of 4-day collections. secondary outcomes (faecal dry weight, defaecation frequency, stool consistency, ease of stool passage, total colonic transit time and gastrointestinal symptoms) were also explored. 51 subjects participated in a 4-week, two-center, randomized, double-blind, placebo-controlled, parallel study testing a control (con) and a pdx treatment (18 g/d included in biscuits and drink mixtures)


Eligibility criteria:
inclusion criteria: 1. mildly constipated healthy adults (who defecate 3- 5 days per week assessed by a 7-day bowel diary) 2. provision of signed and dated informed consent prior to any study procedures 3. body mass index (bmi) ≥ 19 and ≤ 29 kg/m2 at the screening visit 4. total score on fibre intake questionnaire max 17 points for women and 20 points for men (where each point represents approximately 1 g fibre intake) 5. use of adequate contraception in females of childbearing potential exclusion criteria: 1. regular use of laxatives 2. use of medication which alters study subjects' gastrointestinal function (e.g. including but not exclusive neuroleptic medication, medication for parkinson disease, opioids) 3. history of digestive disease (e.g. celiac disease, crohn's disease, ulcerative colitis, gastrointestinal malignancy, fistula of intestine, ischemic colitis, bile acid malabsorption, repeated diverticulitis) 4. type i and ii diabetes 5. previous major gastrointestinal surgery (e.g. intestinal resection, total gastrectomy, subtotal gastrectomy) or surgical treatment of obesity (within 6 months before the screening visit) 6. present cancer (except basal cell skin cancer or squamous cell skin cancer, carcinoma in situ) 7. untreated thyroid disease 8. history of stroke or myocardial infarction within six months prior the screening visit 9. subjects who were actively dieting for weight loss, or had eating disorders (anorexia, bulimia) 10. lack of compliance to the study procedures 11. females who were pregnant or breast-feeding or planning pregnancy 12. known or suspected abuse of alcohol (more than 14 units of alcohol per week, one unit = 4 cl spirit, 12 cl wine or 33 cl medium strong beer / cider), 13. allergy/hypersensitivity/intolerance to study products 14. vegetarians or regularly consuming fibre supplements/fibre supplemented foods 15. any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the study

Keywords: polydextrose mild constipation faecal bulk bowel function clinical trial fibre
a study comparing duloxetine and placebo in the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.


Eligibility criteria:
inclusion criteria: * male or female patients * aged 18 and older who meet criteria for fibromyalgia as defined by the american college of rheumatology * have a score of at least 4 on the average pain item of the brief pain inventory (bpi) (modified short form) at visits 1 and 2 * all females must test negative for pregnancy at the time of enrollment * have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator. exclusion criteria: * have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures * have regional pain syndrome, multiple surgeries or failed back syndrome * have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
[s,s]-reboxetine dose-range finding trial

Conditions: Pain

Summary: the purpose of this study is to determine the effectiveness of different doses of \[s,s\]-reboxetine in the treatment of chronic pain following a shingles infection


Eligibility criteria:
inclusion criteria: * patients must have pain present for more than 3 months after the healing of shingles skin rash * patients at screening must have a score \>/=40 mm on the pain visual analogue scale exclusion criteria: * patients with significant renal and hepatic impairment * patients with other severe pain, that may impair the self-assessment of the pain due to shingles * patients with clinically abnormal electrocardiogram
tilted gaze target test in the examination of children with superior oblique muscle palsy

Conditions: Children With Torticollis

Summary: this study is a prospective, randomized, double-blind cohort study aimed at assessing the accuracy of the preoperative tilted gaze target test in predicting the degree of improvement in compensatory head position after surgery in children with superior oblique muscle palsy.

this is a prospective, randomized, double-blind cohort study conducted from may 2023 to april 2024. the study aims to evaluate the effectiveness of a non-human contact gaze tilt test in the diagnosis of children with superior oblique muscle palsy. patients who met the inclusion criteria for outpatient and inpatient ophthalmic surgery for strabismus and pediatric ophthalmology were enrolled after signing a written informed consent. the gaze tilt test was added to the normal treatment process and performed by a professional ophthalmologist who was not involved in the treatment process. the test involved playing a small animated video with a visual mobile device at a distance of 33 cm and 3 m, respectively, to determine the optimal angle of head position improvement and the spatial tilt angle of the screen relative to the orthostatic position. a third-party analysis of the data was performed to identify myotonic and oculocutaneous tilts and compared with the results of the conventional test. the study aims to clarify the authenticity, reliability, and practicality of the gaze object tilt test in diagnosing and treating oculocutaneous squint.

Eligibility criteria:
inclusion criteria: * age between 1 and 8 years old. * history of torticollis less than 5 years. * ability to cooperate with basic examinations at the tianjin ophthalmology strabismus and pediatric ophthalmology clinic. * complete clinical information available. * signed informed consent. exclusion criteria: * both eyes cannot look at the same time or alternately * children with ocular disease other than oculomotor eye disease. * clearly defined systemic developmental abnormalities: down syndrome, microcephaly, autism, leber syndrome, central visual impairment, etc. * children who cannot cooperate with the examination due to age or other reasons.

Keywords: tilted gaze superior oblique muscle palsy strabismus diagnosis projection
effects of acupressure and foot massage on pain during heel lancing in neonates

Conditions: Acute Pain

Summary: aim: the study was aimed to identifying the effects of foot massage and acupressure on pain during heel lancing in neonates. methods: a single-blinded randomized controlled trial was performed in a university hospital in turkey between april-december 2018. neonates were randomized into three groups as acupressure, massage and control groups. data were obtained by using information form, neonatal infant pain scale (nips), pulse oximeter device and chronometer. acupressure was applied to the neonates in the acupressure group and massage was given to the neonates in the massage group for 2 minutes before heel lancing procedure. pain levels of the neonates in the groups were evaluated during and 1 minute after heel lancing procedure. furthermore, the oxygen saturation and heart rate values of the neonates in the groups were measured by pulse oximeter device before, during and after heel lancing procedure. duration of crying and heel lancing procedure were recorded by chronometer.

massage is a systematic and scientific procedure applied by using hands or special tools. as for acupressure, it is a method applied by stimulating the acupuncture points using hands and fingers by applying pressure on the meridians in body.both methods are reliable, economic and easy to learn and apply. review of the related literature indicates studies on the effectiveness of acupressure and foot massage on reducing pain in neonates.

Eligibility criteria:
inclusion criteria: * having 2500-4000 gr body weight and being term neonates, * having apgar score of over 7 five minutes after birth, * having no health problems detected in the newborn examination after birth, * having received no painful interventions apart from hepatitis b and kvit after birth, * being with the mother and being fed orally, * having had breast milk within 30 minutes before heel lancing * having a clean diaper.

Keywords: acupressure massage pain neonate heel lancing
a study of ixekizumab (ly2439821) in participants with nonradiographic axial spondyloarthritis

Conditions: Axial Spondyloarthritis

Summary: the main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bdmard) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axspa).


Eligibility criteria:
inclusion criteria: * are ambulatory. * diagnosis of nonradiographic axial spondyloarthritis (nr-axspa) and fulfilling the 2009 assessment of spondyloarthritis international society (asas) classification criteria. * have a history of back pain ≥3 months with age at onset \<45 years. * have active nr-axspa defined as basdai ≥4 and total back pain ≥4 on a numeric rating scale (nrs) at screening and baseline. * have objective signs of inflammation by presence of sacroiliitis on mri and/or presence of elevated c-reactive protein (crp). * in the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (nsaids) for duration of 4 weeks or cannot tolerate nsaids. * if taking nsaids be on stable dose for at least 2 weeks prior to randomization. * have a history of prior therapy for axspa for at least 12 weeks prior to screening. exclusion criteria: * have radiographic sacroiliitis fulfilling the 1984 modified new york criteria. * have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents. * have received a live vaccine within 12 weeks or have had a vaccination with bacillus calmette-guerin (bcg) within the past year. * have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis. * have a compromised immune system. * have any other serious and/or uncontrolled diseases. * have either a current diagnosis or a recent history of malignant disease. * have had major surgery within 8 weeks of baseline, or will require surgery during the study. * are pregnant or breastfeeding. * have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.

Keywords: ankylosing nonradiographic spondyloarthritis
assure wcd clinical evaluation - detection and safety study

Conditions: Cardiac Arrest, Sudden

Summary: a prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the assure™ wearable cardioverter defibrillator (wcd).

a prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the assure™ wearable cardioverter defibrillator (wcd). a total of 130 adult subjects at risk for sudden cardiac arrest but otherwise protected by an implantable cardioverter defibrillator (icd) will be enrolled at 10 clinical sites in the united states. subjects will wear the device for approximately 30 days during normal daily activities including sleep. the wcd shock alarms and shock functionality will be disabled. shock alarm event markers are recorded by the wcd and will be used for analysis of the primary outcome measure. all episodes recorded by the assure wcd and/or the subject's icd will be reviewed by independent clinical experts.

Eligibility criteria:
inclusion criteria: 1. males or females, age ≥ 18 years 2. patients with an active implantable cardioverter defibrillator (icd) 3. left ventricular ejection fraction (lvef) ≤ 40%, measured within the past year (12 months) by echocardiography, nuclear imaging (including mri), or left ventricular angiography 4. able and willing to provide written informed consent before undergoing any study-related procedures exclusion criteria: 1. any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements, including cognitive and/or physical limitations that would prevent the subject from interacting with the device as intended 2. any known skin allergy or sensitivity to the study garment materials that will be next to the skin 3. any breached or compromised skin on the upper body that would be exacerbated by wearing the study garment 4. work with or are frequently around equipment that produces high electromagnetic fields, for example magnetic resonance imaging devices, power supply facilities, or welding equipment 5. any planned surgical or medical procedures during the participation period that would require the subject to remove the study device for more than 12 hours 6. any planned air travel during the participation period 7. pregnancy 8. use of mechanical circulatory support, including but not limited to left ventricular assist device (lvad) or total artificial heart 9. implanted cardiac resynchronization therapy defibrillator (crt-d) 10. simultaneous plan/prescription for holter monitor, mobile cardiac outpatient telemetry (mcot), event recorder, or in-hospital telemetry 11. use of any electronic medical device that is worn on or near the body requires sponsor approval, other than continuous positive airway pressure (cpap), continuous blood glucose monitor, or pulse oximeter oxygen saturation (spo2) monitor. 12. under bust chest circumference greater than 52 inches or less than 28 inches 13. current hospital inpatient
electromyographic assessment of the shoulder stabilizing musculature in crossfit® athletes

Conditions: Muscle Strain; Electromyography; Trapezius Muscle Strain

Summary: this is an observational analytical study of prevalent cases and controls.

approximately 39 subjects who practice crossfit at least 6 hours a week are invitated to participate in this observational study. it will measure the activation of trapezius and serratus muscles by electromyography experiencing a feeling of fatigue 7-8 in pushpress and pullups.

Eligibility criteria:
inclusion criteria: * practicing crossfit® for at least 1 year * a minimum of 6 hours per week crossfit® training * no shoulder pain at the time of measurement exclusion criteria: * tendinitis * bursitis * sistematic disease * nurological disease * central or periferic disease

Keywords: serratus muscle strain
effects of training rhythmic and discrete aiming movements on arm control and functionality after stroke

Conditions: Stroke

Summary: the purpose of this study is to verify the additional effects of rhythmic specific training, discrete specific training additional to conventional therapy on the upper limb after chronic stroke subjects on the outcomes: motor control and functionality.

seventy-five patients will be randomized into three groups to receive conventional therapy, consisting of a combination of mobility exercises joint, muscle stretching, strength training, motor coordination exercises, unilateral and bilateral motor tasks as well as oriented tasks training upper limb with a focus on functional tasks. the other groups will receive additional intervention consisting of aiming movement practice according two different protocols: discrete movements to targets placed in different directions and distances; and rhythmic movements also to targets placed in different directions and distances. both additional interventional interventions will be conducted for 30 minutes over a 5 week-period (total: 10 sessions). clinical outcomes (motor control), functional and kinematic will be collected at baseline and at five weeks. functional results will be collected at the beginning, after 5 weeks and 3 months after randomization. data will be collected by a blinded assessor on patients' allocation group. all statistical analyzes will be carried out following the principles of intention to treat analysis and differences between groups will be performed using linear mixed models.

Eligibility criteria:
inclusion criteria:patients who participate in the survey, adult stroke survivors (\>18 years), with primary diagnosis of first-ever unilateral stroke (ischaemic or haemorrhagic), stroke experienced \> 6 months prior to study enrollment and score ≥ 20 on the folstein mini mental status examination. exclusion criteria: patients with excessive pain in the paretic hand, arm or shoulder excessive spasticity at the paretic elbow and wrist as defined as a score of 4 on the modified ashworth spasticity scale and upper limb comorbidities that could limit their functional recovery (e.g., arthritis, pain, other neurological disorders).

Keywords: exercise rhythmic movement discrete movement
effect of genetic polymorphism on capecitabine-induced toxicity in egyptian cancer patients

Conditions: Colorectal Cancer; Breast Cancer

Summary: the goal of this observational study is to study the effect of a single nucleotide polymorphism in the ces1 gene (rs2244613) on capecitabine-induced toxicity in egyptian cancer patients. this study will help in understanding the interindividual variability in the ces1 gene and the effect of a single nucleotide polymorphism in this gene (rs2244613) on capecitabine-induced toxicity in participants already taking capecitabine-based chemotherapy as part of their regular medical care.


Eligibility criteria:
inclusion criteria: * patients with breast or colorectal cancer receiving capecitabine-based chemotherapy * age \> 18 years * ecog ps 0-2. exclusion criteria: * patients treated with irinotecan * lack of physical integrity of the upper gastrointestinal tract * patients with malabsorption syndrome * patients having inability to take oral medication * patients with poor performance status * patients with chronic diarrhea as ulcerative colitis or crohn's disease

Keywords: polymorphism ces1 capecitabine toxicity cancer
comparison of sedation/analgesia: midazolam/morphine vs propofol/remifentanil

Conditions: Shoulder Dislocation

Summary: for reduction of dislocated shoulder, sedation with propofol and remifentanil should give satisfactory operating conditions and pain relief, and significantly reduce the time to full recovery, compared with morphine and midazolam

propofol is a recognised agent for sedation and remifentanil is a short acting opioid analgesic. we intend to provide sedation with propofol, 0.5 mg/kg, and analgesia with remifentanil 0.5 microgram/kg for reduction of dislocated shoulders. this will be a randomised sex-stratified comparison with current therapy which is midazolam incrementally up to a maximum of 0.15 mg/kg, and morphine incrementally up to 0.15 mg/kg. the primary outcome measure is time to full recovery. secondary aspects are pain or discomfort during the procedure and operating conditions.

Eligibility criteria:
inclusion criteria: - anterior dislocation of the shoulder suitable for manual reduction exclusion criteria: * significant other illness * body weight 25% greater than expected * fear of oxygen masks * alcohol intoxication

Keywords: sedation propofol remifentanil recovery
neoadjuvant trial of capecitabine for axillary lymph node positive operable breast cancer

Conditions: Stage II Breast Cancer; Stage III Breast Cancer

Summary: this randomized phase ii trial compared pathologic response rates (pcr) of early breast cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(fec) and capecitabine-epirubicin-cyclophosphamide (xec).


Eligibility criteria:
inclusion criteria: * females aged 18-70 with histologically proven, core-biopsied, stage ii-iii invasive breast cancer * no distant disease exclusion criteria: - inadequate heart or liver or kidney function

Keywords: capecitabine neoadjuvant therapy early breast cancer
challenges in management of abdominal trauma in sohag university hospital a prospective study

Conditions: Abdominal Trauma

Summary: the present study will be conducted to evaluate the different patterns of abdominal trauma patients and their management in the emergency department of sohag university hospital

the present study will be conducted to evaluate the different patterns of abdominal trauma patients and their management in the emergency department of sohag university hospital this study will be a prospective study which will be conducted at the emergency department of sohag university hospital the study population include all patients with abdominal trauma

Eligibility criteria:
inclusion criteria: * any patient presented with abdominal trauma exclusion criteria: * patients with extra abdominal injuries
pharmacokinetics of cefepime and aai101 in subjects with renal insufficiency and healthy subjects

Conditions: PK in Patients With Various Degrees of Renal Impairment

Summary: this is a phase 1, multi-center, open-label, pk and safety study of a single dose of aai101 in combination with cefepime in male and female subjects with mild renal impairment (group 1, n = 6), moderate renal impairment (group 2, n = 6), severe renal impairment (group 3, n = 6), esrd requiring dialysis (group 4, n = 6), and normal renal function (group 5, n = 6) as defined using the estimated value for creatinine clearance (clcr) at screening. the study consists of a 28-day screening period, followed by a single dose administration of aai101 in combination with cefepime antibiotic on day 1, an in house period (assessment period) and follow-up visit. all subjects will be confined to the study site from day -1 (the day before dosing) until the morning of day 3. the follow-up visits will occur on day 7 (±2 days), on day 14 (±2 days), and on day 30 (±2 days), if the results of the safety hepatic assessments are abnormal on day 14 (±2 days). group 4 (esrd requiring dialysis) will have 2 in-house periods (separated by at least 7 days), and will receive the single doses of aai101 in combination with cefepime antibiotic once after dialysis and once before dialysis. the follow-up visit for group 4 will occur on day 7 (±2 days), on day 14 (±2 days), and on day 30 (±2 days), if the results of the safety hepatic assessments are abnormal on day 14 (±2 days), counting from day 1 of the second period.


Eligibility criteria:
main inclusion criteria * adult male or female subjects age 18 to 70 years, inclusive * bmi 18.0 35.0 kg/m2, inclusive, where bmi (kg/m2) = body weight (kg) / height2 (m2) subjects with renal impairment (in addition) * stable renal impairment, defined as no clinically significant change in disease status, as judged by the investigator healthy subjects (in addition) * subjects with normal renal function as evidenced by clcr * judged to be in good health in the opinion of the investigator on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality or subject has a stable disease (e.g., hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control.